On March 11, 2014 a periodic safety update was reported to have been added to the EPAR for Yervoy (External Source EMA, Bristol-Myers Squibb, MAR 11, 2014, View Source [SID:1234500262]).
A review of cases of anaphylaxis or cytokine release syndrome events identified a total of 6 cases: two of the 6 cases had limited information for assessment. Nevertheless, there have been cases of anaphylactic reactions, resulting in hospitalization in at least one patient; and for which stopping the medication and supportive care was needed in all reported cases. Due to the characteristics of the cases (rapid time to onset and severity of the events) the PRAC considered that anaphylactic reactions should be included in section 4.8 of the SmPC, with a frequency based on clinical trials, i.e. very rare (<0.01% (1/12881)). The package leaflet is updated accordingly. The CHMP agrees with the scientific conclusions made by the PRAC. Commission decision was issued on DEC 18, 2013.